Spesolimab-sbzo
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Overview
Spesolimab-sbzo is {{{aOrAn}}} humanized monoclonal Immunoglobulin G1 antibody that is FDA approved for the treatment of generalized pustular psoriasis (GPP) flares in adults.. Common adverse reactions include infections, nausea, vomiting, headache, fatigue, Infusion site hematoma and bruising..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults.
SPEVIGO is administered as a single 900 mg dose by intravenous infusion over 90 minutes. However, an additional intravenous 900 mg dose is administered over 90 minutes after one week of the initial dose, if the GPP persists.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
The safety and effectiveness of SPEVIGO in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Contraindications
SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo such as anaphlaxis and DRESS syndrome. It is also contraindicated in patients active infections.
Warnings
- Infection
SPEVIGO increases the risk of infection. Therefore, Patients with clinicaly active infection are advised to avoid SPEVIGO, until the infection is adequately treated or resolved.
- Risk of tuberculosis
Evaluate the patient for tuberculosis infection. Avoid SPEVIGI in patients with tuberculosis. Patients should be started with anti-TB treatment before SPEVIGO if they have latent TB or a history of inadequate treatment course of TB.
- Hypersensitivity and infusion relation reaction
SPEVIGO may be associated with serious life-threatening hypersensitivity reactions:
- immediate reaction-anaphylaxis
- delayed reaction-DRESS syndrome
In either situation, immediately discontinue SPEVIGO and initiate appropriate management. Patients may also develop mild-moderate infusion related reaction. In such a situation, withhold the SPEVIGO infusion and administer appropriate medical therapy like systemic antihistamines and/or corticosteroids. Once the reactions have subsided, restart the infusion at a slower rate gradually.
- Vaccination
Avoid the use of live vaccines in patients treated with SPEVIGO.
Adverse Reactions
Clinical Trials Experience
- Asthenia and Fatigue
- Nausea and Vomiting
- Headache
- Pruritus and prurigo
- Infusion site hematoma and bruising
- Urinary tract infection
- Bacteremia
- Bacteriuria
- Upper respiratory tract infection
- Cellulitis
- Herpes dermatitis and oral herpes
- Urticaria
- Dyspnea
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- Anaphylaxis
- Among approximately 750 subjects exposed to SPEVIGO during clinical development, Guillain-Barre syndrome (GBS) was reported in 3 subjects.
Postmarketing Experience
There is limited information regarding Spesolimab-sbzo Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Spesolimab-sbzo Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): B
The limited data on the use of SPEVIGO in pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes.
However, since Human Immunoglobulin-G is transmitted to the fetus via the placenta, SPEVIGO may be transmitted from the mother to the developing fetus.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Spesolimab-sbzo in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Spesolimab-sbzo during labor and delivery.
Nursing Mothers
There are no data on the presence of spesolimab-sbzo in human milk, the effects on the breastfed infant, or the effects on milk production. Spesolimab-sbzo is a monoclonal antibody and is expected to be present in human milk.
Pediatric Use
safety and effectiveness of SPEVIGO in pediatric patients have not been established.
Geriatic Use
Clinical studies of SPEVIGO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger adult subjects.
Gender
There is no FDA guidance on the use of Spesolimab-sbzo with respect to specific gender populations.
Race
There is no FDA guidance on the use of Spesolimab-sbzo with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Spesolimab-sbzo in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Spesolimab-sbzo in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Spesolimab-sbzo in women of reproductive potentials and males.
Immunocompromised Patients
Since the SPEVIGO increases the risk of infection, it is best advised to avoid its use among patients who are immunocompromised or who are currently on immunosuppressants.
Administration and Monitoring
Administration
There is limited information regarding Spesolimab-sbzo Administration in the drug label.
Monitoring
There is limited information regarding Spesolimab-sbzo Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Spesolimab-sbzo and IV administrations.
Overdosage
There is limited information regarding Spesolimab-sbzo overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Spesolimab-sbzo Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Spesolimab-sbzo Mechanism of Action in the drug label.
Structure
There is limited information regarding Spesolimab-sbzo Structure in the drug label.
Pharmacodynamics
There is limited information regarding Spesolimab-sbzo Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Spesolimab-sbzo Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Spesolimab-sbzo Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Spesolimab-sbzo Clinical Studies in the drug label.
How Supplied
There is limited information regarding Spesolimab-sbzo How Supplied in the drug label.
Storage
There is limited information regarding Spesolimab-sbzo Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Spesolimab-sbzo Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Spesolimab-sbzo interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Spesolimab-sbzo Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Spesolimab-sbzo Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.